(b)(6).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4).It was visually inspected and the inspiratory and expiratory heater wires were resistance tested with a calibrated multimeter.Results: visual inspection of the expiratory limb revealed cracks on both the distal and proximal connectors.The expiratory limb was cracked approximately 10 - 20 mm from the proximal connector.It was also slightly discoloured and dark marks were noted approximately 90mm from the distal connector.Visual inspection of the inspiratory limb revealed damage to the tube near the proximal connector.The resistance test showed that both the inspiratory and expiratory heater wires were within specification.The hospital provided further information to a fph representative which indicates that the returned circuit was sterilized and reused on multiple patients.The hospital further informed us that the returned circuit was actually used for eight days and not seven.The hospital also informed us that it is their standard protocol to sterilize and reuse single use breathing circuits.Conclusion: the rt265 infant dual heated evaqua2 breathing circuit is a single use device that is intended to be used for a maximum of seven days.A caution tag is attached to the inspiratory limb of the rt265 warns the user of the seven day intended use.Furthermore, the user instructions that accompany the rt265 state: "this product is intended to be used for a maximum of 7 days." "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." since the reported incident a fph representative has been in contact with the hospital staff.We are also in the process of formally writing to them to reiterate our user instructions that fph single use breathing circuits are not to be cleaned or reused.
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